HospitalInspections.org

Based on interview and record review, the facility failed to manage the hospital.

These failures resulted in orders not being carried out at the appropriate time and had to potential to result in patient harm, ineffective drug therapy, negative impact on the drug's intended therapeutic effect, delays in clinical improvement, extended length of hospital stay, inadequate notification in a timely manner to the physician responsible for the patient's care, and/or health care staff practicing outside scope of practice for a universe of three (Patient 2, Patient 17, and Patient 18) of 18 sampled patients.

In addition, this failure jeopardized the health and safety of a universe of 3,248 patients who visited the Emergency Department and/or a universe of 1,883 patients admitted to the hospital between the August 30, 2019, to November 1, 2019, who could have been exposed to preventable medication errors and/or administered potentially contaminated IV (intravenous - into the patient's vein) medications prepared on the patient care units which could increase the patient's risk of adverse health outcomes, such as infections.

Findings:

A review of the facility document titled "RULES AND REGULATIONS OF THE GOVERNING BOARD [committee responsible for the legal conduct of the hospital] OF [the name of the healthcare system]" dated January 1, 2014, indicated "ARTICLE I [one] THE GOVERNING BOARD FUNCTIONS AND DUTIES. The functions and duties of the Governing Board ...(h) Assure that all services furnished on a contract basis at or by the Hospital meet the standards set forth by the Governing Board, Hospital Administration and the Medical Staff, and further that such services are being furnished in compliance with all applicable federal, state ...agency requirements ...ARTICLE IX [nine] CHIEF EXECUTIVE OFFICER [CEO - the most senior administrator in charge of managing the hospital] ...Compliance with Laws and Regulations. The Hospital CEO shall review and act promptly upon the reports of authorized ...regulatory and inspection agencies and shall report to the Governing Board on the overall activities of, and developments and inspections affecting, the Hospital. The Hospital CEO shall undertake corrective action for any deficiencies reported by such agencies."

A review of the facility policy and procedure titled "PERFORMANCE IMPROVEMENT PLAN" dated August 2019 indicated "The Governing Board has the authority and responsibility for establishing and maintaining [the name of the hospital] Performance Improvement (PI) Plan. The Governing Board has delegated to the Medical Executive Committee (medical staff leadership) and Chief Executive Officer the responsibility for implementation of the program. It is their duty to assure patient care is safely delivered within the guidelines established by the medical staff and hospital leadership while meeting all standards and regulations."

During an interview with the Director of Pharmacy (DOP) on October 23, 2019, at 2:41 PM, the DOP stated the hospital's pharmacy stopped compounding (mixing drugs) on August 30, 2019, at 5 PM. The DOP stated no other hospital is making medications for the hospital at the moment. The DOP stated nursing staff was making emergency drugs.

During an interview with the DOP and Chief Operating Officer (COO) on October 24, 2019, at 1:38 PM, the DOP and COO stated there was no policy and procedure on nurse admixture (compounding) of IV drugs.

During a document request to demonstrate training and dated competencies on nurse admixture of IV drugs, the DOP, COO, Director of Clinical Education, and Interim Director of Quality were unable to produce documentation by October 25, 2019, at 4:48 PM, to show nursing staff were trained and competent before compounding intravenous (IV - into the patient's vein) medications.

During an interview with the DOP on October 29, 2019, at 4:10 PM, the DOP stated the hospital's policy was to follow "USP <797> [United States Pharmacopeia - establishes quality standards for drug compounding]" standards of practice for sterile compounding.

During record review and concurrent interview with the DOP on October 30, 2019, at 10:28 AM, Patient 18's record review was continued with the DOP. The DOP stated the norepinephrine infusion was a premix. The DOP acknowledged that the documentation indicated "Immediate Use Kit Delivery Log" indicated nursing staff prepared two individual norepinephrine infusions on September 4, 2019. The DOP stated the Pharmacy Department ran out of the norepinephrine infusion premixes and "maybe someone forgot to order". The DOP stated the pharmacy "cannot plan" so the medications do not run out of stock.

During an interview with the DOP on October 30, 2019, at 10:51 AM, the DOP stated the sister facility was located in downtown Los Angeles and traffic is a big factor in obtaining medications from the sister facility.

During record review and concurrent interview with the DOP and the COO on October 31, 2019, at 2:13 PM, an email dated September 10, 2019, at 5:09 PM and titled "Nursing compounding Competencies" was reviewed. The DOP stated this email contained the three attachments titled "Nursing Sterile Compounding Competencies Test.docx, Answer key to nursing competency test.docx, and USP 797 Nursing.docx." The DOP acknowledged that these documents were distributed to nursing leadership on September 10, 2019, at 5:09 PM (time period between the pharmacy compounded area was closed to when pharmacy distributed nursing compounding competencies via email was 11 days).

During an interview with the Nurse Director 1 (ND 1) on October 31, at 3:30 PM, the ND 1 stated the time window policy was 30 minutes before or after for an antibiotic medication ordered with a frequency of 12 hours.

During interview with the ND 1 on November 1, 2019, at 9:39 AM, the ND 1 stated there was no requirement to document physician notification in the medical record. The ND 1 stated the "Doctors see the MAR [Medication Administration Record - section of the medical record where administered drugs are documented]. Physicians need to go see MAR."

During record review and concurrent interview with Registered Pharmacist 2 (RPh 2) on November 1, 2019, at 11:11 AM, Patient 17's medical record was reviewed with RPh 2. The medical record indicated an IV fluid order containing dextrose (sugar) 5% (concentration) 1000 milliliters (mL - a unit of measurement) with 40 milliequivalents (mEq) of the potassium chloride (supplement) to infuse continuously at a rate of 70 mLs per hour. The medical record indicated the IV fluid order had a "Start Date" of August 31, 2019, at 1 PM, and a "Stop Date" of September 4, 2019, at 6:01 PM. The medical record indicated three IV fluid bags were administered to Patient 17 on September 2, 2019, at 12:41 AM; on September 3, at 6:50 AM; and September 4, 2019, at 6:20 AM. During a concurrent interview, RPh 2 acknowledge the physician's order. The RPh 2 stated the IV fluid order was not started on time "because we are trying to avoid compounding."

During record review and concurrent interview with the Registered Pharmacist 2 (RPh 2) and ND 1 on November 1, 2019, at 9:39 AM, Patient 2's medical record was reviewed. RPh 2 stated that antibiotics are time-critical medications. The RPh 2 stated the it is "9 [AM] and 2100 [9 PM]" for the policy about the schedule for medications ordered every 12 hours. The ND 1 stated "we are at the mercy of the outside dialysis group." The ND 1 stated she was unfamiliar with their hours because they are a contracted service. The ND 1 stated "if we [the hospital] have to do that" [follow policy] for every antibiotic, the hospital would have to have dialysis for 24 hours. The ND 1 stated "it [dialysis] is contracted service, we can't dictate it around antibiotic timing."

During a QAPI group interview with the COO, Vice President, Quality & Patient Safety (VPQPS), Quality Manager, and DOP, on November 5, 2019, at 3:00 PM, QAPI oversight regarding medication-related issues were discussed. The DOP stated that no "IV compounding-related (mixing and preparing drugs)" policies and procedures were modified or developed between August 30, 2019 (when the hospital's pharmacy compounding area closed) to October 22, 2019 (entrance date of the revisit survey). The DOP stated it was only the pharmacy department auditing the "Immediate Use Kit Delivery Log" for quality assurance.

During a Governing Body (GB) group interview with the Chief Executive Officer (CEO), Chief Operating Officer, Vice President, Quality & Patient Safety, and Director of Pharmacy, on November 5, 2019, at 3:45 PM, GB oversight for medication-related issues were discussed. The hospital's pharmacy compounding area had been closed since August 30, 2019. The GB was asked when it became aware that IV medications were not being obtained from the sister facility. The CEO stated it would have been when the POC (Plan of Correction) was reviewed. The CEO stated he could not recall the date.

Based on interviews and record review, the facility failed to ensure pharmaceutical services to meet the needs of patients. This occurred when:

1. For three (Patient 2, Patient 17, and Patient 18) of 18 sampled patients, medications were not available for patient administration when the facility did not obtain IV (intravenous - into the patient's vein) medication from external (outside) sources when the pharmacy compounding (mixing medications) area was closed and/or did not have sufficient stock (drug inventory) in the Pharmacy to anticipate patient needs based on the physician's ordered duration.

2. The facility could not demonstrate for one (Patient 2) of 18 sampled patients, the patient received the correct dose of the antibiotic ceftaroline (drug to treat infection) to ensure safe and effective drug therapy.

These failures had to potential to result in patient harm, delays in clinical improvement, and/or extended length of hospital stay for a universe of three (Patient 2, Patient 17, and Patient 18) of 18 sampled patients.

In addition, this failure jeopardized the health and safety of a universe of 3,248 patients who visited the Emergency Department and/or a universe of 1,883 patients admitted to the hospital between the August 30, 2019, to November 1, 2019, who could have been exposed to preventable medication errors and/or administered potentially contaminated IV (intravenous - into the patient's vein) medications prepared on the patient care units which could increase the patient's risk of adverse health outcomes, such as infections.

Findings:

1. During an interview with the Director of Pharmacy (DOP) on October 28, 2019, at 12:07 PM, the DOP stated there was no plan if patients needed a medium risk level (category of contamination risk level) compounded sterile preparations (CSPs).

During record review and concurrent interview with Registered Nurse 2 (RN 2) on October 28, 2019, at 4:50 PM, Patient 2's medical record was reviewed with RN 2. The medical record indicated a medication order for the antibiotic ceftaroline, with an ordered frequency of every 12 hours, a start date of September 20, 2019, at 9:41 AM, and a stop date of October 3, 2019, at 5:25 PM. During a concurrent interview, RN 2 acknowledged the above ceftaroline medication order.

During record review and concurrent interview with the DOP on October 29, 2019, at 4:35 PM, Patient 2's medication order for the antibiotic ceftaroline with an ordered frequency of every 12 hours was reviewed with the DOP. The medical record contained a "Nursing Narrative Note" dated September 21, 2019, at 12:24 PM, which indicated "1130 [11:30 AM] Spoke with [the name of Registered Pharmacist 1] from pharmacy and stated that IVPB [Intravenous Piggyback] Ceftaroline is unavailable at the pharmacy at this time." The DOP requested to follow-up with the survey team regarding Patient 2 on October 30, 2019.

During record review and concurrent interview with the DOP on October 29, 2019, at 4:47 PM, Patient 18's medication order for norepinephrine (generic name for Levophed - drug to treat low blood pressure in critically ill patients) infusion (drip) and the facility document titled "Immediate Use Kit Delivery Log" were reviewed with the DOP. The norepinephrine infusion medication order indicated a dose of 5 micrograms (unit of measurement) per minute with a start date of September 3, 2019, and a discontinue date of September 29, 2019. The "Immediate Use Kit Delivery Log" indicated nursing staff prepared two individual norepinephrine infusions on the patient care unit on September 4, 2019 at 5:07 AM and 11:55 PM (calculated time difference for nursing compounding the two norepinephrine infusions is 18 hours and 48 minutes). The DOP stated the norepinephrine infusion was stocked in the Pharmacy as a premix (commercially available and ready to use). The DOP requested to follow-up with the survey team regarding Patient 18 on October 30, 2019.

During record review and concurrent interview with the DOP on October 30, 2019, at 10:28 AM, Patient 18's record review was continued with the DOP. The DOP stated the norepinephrine infusion was a premix. The DOP acknowledged that the documentation indicated "Immediate Use Kit Delivery Log" indicated nursing staff prepared two individual norepinephrine infusions on September 4, 2019. The DOP stated the Pharmacy Department ran out of the norepinephrine infusion premixes and "maybe someone forgot to order". The DOP stated the pharmacy "cannot plan" so the medications do not run out of stock.

During record review and concurrent interview with the DOP on October 30, 2019, at 10:32 AM, Patient 2's record review was continued with the DOP. The DOP stated "this is another missed medication that was not ordered properly. The order was missed on Friday [September 20, 2019]. On Saturday [September 21, 2019], the nurse called, they [the pharmacy staff] said it was not available."

During an interview with the DOP on October 30, 2019, at 10:51 AM, the DOP stated the sister facility was located in downtown Los Angeles and traffic is a big factor in obtaining medications from the sister facility.

During record review and concurrent interview with Registered Pharmacist 2 (RPh 2) on November 1, 2019, at 11:11 AM, Patient 17's medical record was reviewed with RPh 2. The medical record indicated an IV fluid order containing dextrose (sugar) 5% (concentration) 1000 milliliters (mL - a unit of measurement) with 40 milliequivalents (mEq) of the potassium chloride (supplement) to infuse continuously at a rate of 70 mLs per hour. The medical record indicated the IV fluid order had a "Start Date" of August 31, 2019, at 1 PM, and a "Stop Date" of September 4, 2019, at 6:01 PM. The medical record indicated three IV fluid bags were administered to Patient 17 on September 2, 2019, at 12:41 AM; on September 3, at 6:50 AM; and September 4, 2019, at 6:20 AM. During a concurrent interview, RPh 2 acknowledge the physician's order. The RPh 2 stated the IV fluid order was not started on time "because we are trying to avoid compounding."

During an interview with the Chief Operating Officer (COO) and the DOP on November 1, 2019, at 2:20 PM, the COO and DOP stated they need to contact the California State Board of Pharmacy to ask if they if they could outsource the IV medications from a sister hospital. The COO and DOP stated the Plan of Correction (POC) language for the previous July 2019 revisit survey stated "may" so they did not ask the California State Board of Pharmacy when the POC was approved by the state agency.

A review of the facility's document titled "Urgent ***Stop Compounding Effective Immediately 8-30-19***" dated August 30, 2019, at 5:30 PM, indicated "Effective immediately, please stop all IV Sterile Compounding in the Pharmacy ...Use premixes if available, including but not limited to: a. Levophed drip 4 mg and 8mg/250ml ...We will NOT send orders to [the name of the sister hospital]. Pharmacists will change every order appropriate to low risk preparation by making smaller bags."

A review of the facility's document titled "Pharmacy Huddle/Staff Meeting" minutes dated September 3, 2019, at 2:30 PM, indicated "we will not use [the name of the sister facility] for compounding."

A review of the facility's policy and procedure titled "Processing medication Orders" dated March 2019, indicated "Orders requiring clarification due to incomplete, unclear, or illegible handwriting shall be discussed with the prescriber before verification."

A review of the facility's policy and procedure titled "Sterile Compounding" dated August 16, 2019, indicated "References ...USP <797>."

2. During a group interview on October 28, 2019, at 11:48 AM, the COO, DOP, Director of Clinical Education (DCE), and Interim Director of Quality (IDQ), the DCE stated "the [medication] kits are being delivered by the Pharmacy Technician and captured on the log."

During an interview on October 28, 2019, at 12:26 PM, the Pharmacy Technician 4 (RXT 4) stated she had delivered medication kits before. The RXT 4 stated they take the medication kits and log to the patient care unit when they receive the call from the nurse.

During an interview on October 29, 2019, at 11:42 AM, Registered Pharmacist 3 (RPh 3) stated that Patient 2 is a renal (kidney issues) patient who was ordered the antibiotic ceftaroline.

During record review and concurrent interview with the DOP on October 30, 2019, at 10:40 AM, the "Immediate Use Kit Delivery Log" entry for October 2, 2019, at 11:00 PM for Patient 2 was reviewed. In the space for the above entry "Amount added", the volume listed was 20 milliliters (mLs - unit of measurement) of ceftaroline drug added. The instructions indicated on the log indicated "Observe correct amount is added to the diluent [intravenous fluid container]". During a concurrent interview, the DOP acknowledged the pharmacy technician recorded 20 mLs of ceftaroline drug added on the log. The DOP stated the Pharmacy Department has both the 400 mg and the 600 mg medication vials. The DOP was asked to show the correct dose was administered to the patient but was unable to explain if the 400 mg or 600 mg ceftaroline drug vial was used when 20 mLs of drug was added to the diluent. The DOP stated the verifying Registered Pharmacist should have caught the error of 20 mLs of volume recorded on the log on October 2, 2019, at 11:00 PM.

During record review and concurrent interview with Registered Pharmacist 2 (RPh 2) on November 1, 2019, at 10:21 AM, the "Immediate Use Kit Delivery Log" entries for September 15, 2019, at 4:00 AM and 3:15 PM, for Patient 2 was reviewed. In the space for the above entries "Amount added", the volume listed was 20 milliliters (mLs - unit of measurement) of ceftaroline drug added. The instructions indicated on the log indicated "Observe correct amount is added to the diluent". During a concurrent interview, RPh 2 acknowledged 20 mLs of ceftaroline was the "Amount added" to the diluent on September 15, 2019, at 4:00 AM and September 15, 2019, at 3:15 PM. The RPh 2 stated the verifying Registered Pharmacy "should have" questioned the 20 mLs of "Amount added" for September 15, 2019, at 4:00 AM and September 15, 2019, at 3:15 PM.

During record review and concurrent interview with RPh 2 on November 1, 2019, at 10:33 AM, Patient 2's medical record was reviewed with RPh 2. The medical record indicated the first medication order for the antibiotic ceftaroline 200 milligrams (mg - a unit of measurement) with an ordered frequency of every 12 hours with a start date of September 11, 2019, at 11:40 AM and a stop date of September 18, 2019, at 4:49 PM. The instructions for this first order indicated "withdraw 6.67ml from vial and add that back into the bag." The medical record indicated the second medication order for the ceftaroline 200 mg with an ordered frequency of every 12 hours with a start date of September 20, 2019, at 9:41 AM and a stop date of October 3, 2019, at 5:25 PM. The instructions for this second order indicated "withdraw 10 ml from vial and add that back into the bag." During a concurrent interview, the RPh 2 acknowledged the above two ceftaroline medication orders, the pharmacist instructions to withdraw 6.67 mLs from the vial, and the pharmacist instructions to withdraw to 10 mLs from the vial.

During record review and concurrent interview with RPh 2 on November 1, 2019, at 10:33 AM, the "Immediate Use Kit Delivery Log" entries for September 26, 2019, at 3:35 PM and 10:27 PM, for Patient 2 was reviewed. The "Amount added" for the entry for September 26, 2019, at 3:35 PM, was 6.67 mLs of ceftaroline drug. The "Amount added" for the entry for September 26, 2019, at 10:27 PM, was 10 mLs of ceftaroline drug. During a concurrent interview, the RPh 2 acknowledged there were two different volumes of drug (6.67 mLs and 10 mLs) for the amount of ceftaroline added on September 26, 2019 at 3:35 PM and 10:27 PM. The RPh 2 stated, "I know what you are asking but I don't have an answer."

A review of the package insert (document on safe drug administration) for ceftaroline from Drug Manufacturer A (MFG A), obtained from the facility, dated May 2016, indicted the dosage for renal patients is ceftaroline 200 mg every 12 hours.

A review of the facility's policy and procedure titled "Ordering, Preparation, and Administration of Medications" dated April 2019, indicated:
"E. Medication Administration
1. An MD, RN, LVN or student nurse under the direct supervision of an RN, may administer FDA approved and investigational medications in accordance with the Six Rights of medication administration. An RT or PT may administer FDA approved medications within the scope of their practices ...Right dose ...

On November 1, 2019, at 4:23 PM, an Immediate Jeopardy (a situation with the potential to harm the health and safety of patients) was called in the presence of the facility Chief Executive Officer (CEO), Chief Operating Officer (COO), Chief Nursing Officer (CNO), Senior Vice President, Quality & Patient (SVPQPS), and Director of Pharmacy (DOP). The facility Administrators were verbally notified of the hospital's failure of not complying with meeting the needs of patients due to medications not being available for patient administration in compliance with regulatory requirements and/or the current United States Pharmacopeia (USP - establishes quality standards for drug compounding) chapter <797>. The facility did not obtain IV (intravenous - into the patient's vein) from external (outside) sources when the pharmacy compounding (mixing medications) area was closed. The Pharmacy Department did not have sufficient stock (inventory) in the Pharmacy to anticipate patient needs based on the physician's ordered duration. Three patients (Patient 2, Patient 17, and Patient 18) of 18 sampled patients were identified as affected. In addition, this failure jeopardized the health and safety of a universe of 3,248 patients who visited the Emergency Department and/or a universe of 1,883 patients admitted to the hospital between the August 30, 2019, to November 1, 2019, who could have been exposed to preventable medication errors and/or administered potentially contaminated IV (intravenous - into the patient's vein) medications prepared on the patient care units which could increase the patient's risk of adverse health outcomes, such as infections.

On November 5, 2019, at 2:30 PM, the Immediate Jeopardy situation was abated (lifted) in the presence of the COO, DOP, and the Vice President, Quality & Patient Safety (VPQPS). The facility Corrective Action Plan was approved through observation, interview, and record review, as evidenced by the hospital's staff knowledge and review of facility documents.

The Corrective Action Plan included the following components:
1. Written agreement with sister (affiliated) hospital to prepare CSPs when the facility is unable to prepare CSPs in accordance with immediate-use requirements of USP <797>.
2. Memo to Medical Staff, Pharmacy Staff, and Nursing the sister hospital will be contacted to provide CSPs to ensure timely patient care. For Immediate-Use medications with urgent need, the Pharmacy Department will send the first dose. For subsequent doses, the Pharmacy will contact the sister hospital to prepare the CSPs.
3. CSP Request and Receipt Log from sister hospital
4. Updated Immediate Use Kit Delivery Log effective November 4, 2019
5. Registered Pharmacist will deliver Immediate-Use medications to the patient care units instead of the Pharmacy Technician. The Registered Pharmacist will observe, verify, and monitor the IV preparation process at the time of delivery.
6. The Registered Nurse who prepares the bedside low-risk level compounding will be responsible for filling out the updated Immediate-Use log.
7. Education for all Nursing and Pharmacy Department staff on the new process.
8. Pharmacy staff educated on medication acquisition and managing drug inventory.

Based on interview and record review, the facility failed to ensure drug administration errors were reported to the physician for two (Patient 2 and Patient 17) of 18 sampled patients. This occurred when medications were not administered to the patients at the right time to ensure adherence to the prescribed frequency and time of administration. Patient 2 was prescribed an antibiotic (drug to treat infection) to be administered every twelve hours. Patient 17 experienced hypokalemia (low potassium laboratory values) and was prescribed IV fluid solutions with potassium chloride (supplement).

These failures had to potential to result in patient harm, delays in clinical improvement, extended length of hospital stay, inadequate notification in a timely manner to the physician responsible for the patient's care, and/or health care staff practicing outside scope of practice for a universe of 2 patients.

Findings:

During record review and concurrent interview with Registered Nurse 2 (RN 2) and Registered Pharmacist 1 (RPh 1) on October 28, 2019, at 4:11 PM, Patient 2's medical record was reviewed with RN 2 and RPh 1. The medical record indicated the first medication order for the antibiotic ceftaroline 200 milligrams (mg - a unit of measurement), with an ordered frequency of every 12 hours, a start date of September 11, 2019, at 11:40 AM, and a stop date of September 18, 2019, at 4:49 PM. During a concurrent interview, the RPh 1 acknowledged the above physician order with an ordered frequency of every 12 hours. During record review and concurrent interview, the RPh 1 stated the following:

1. antibiotic ceftaroline was administered on September 11, 2019, at 8:14 PM. The next antibiotic administration was on September 12, 2019, at 10:21 AM. RPh 1 stated this was a time difference of 14 hours.

2. antibiotic ceftaroline was administered on September 13, 2019, at 9:14 PM. The next antibiotic administration was administered on September 14, 2019, at 2:52 PM. RPh 1 stated the morning antibiotic should have been given on September 14, 2019, at 10 AM. RPh 1 stated this was 4 hours and 52 minutes late.

3. antibiotic ceftaroline was administered on September 16, 2019, at 3:46 AM. The next antibiotic administration was on September 16, 2019, at 9:03 PM. RPh 1 stated this was a time difference of 17 hours.

4. antibiotic ceftaroline was administered on September 17, 2019, at 4:22 AM. The next antibiotic administration was on September 17, 2019, at 6:20 PM. RPh 1 stated this was a time difference of 14 hours.

5. antibiotic ceftaroline was administered on September 17, 2019, at 6:20 PM. The next antibiotic administration was on September 18, 2019, at 4:49 PM. RPh 1 stated this was a time difference of 22 hours.

During record review and concurrent interview with RN 2 and RPh 1 on October 28, 2019, at 4:50 PM, Patient 2's medical record was reviewed with RN 2 and RPh 1. The medical record indicated the second medication order for the antibiotic ceftaroline, with an ordered frequency of every 12 hours, a start date of September 20, 2019, at 9:41 AM, and a stop date of October 3, 2019, at 5:25 PM. During a concurrent interview, RN 2 acknowledged the above physician order with an ordered frequency of every 12 hours. During record review and concurrent interview, the RPh 1 stated the following:

1. antibiotic ceftaroline was administered on September 20, 2019, at 8:52 PM. The next antibiotic administration was on September 21, 2019, at 9:07 PM. RPh 1 stated this was a time difference of approximately 24 hours.

2. antibiotic ceftaroline was administered on September 22, 2019, at 8:57 PM. The next antibiotic administration was on September 23, 2019, at 1:01 PM. RPh 1 stated this was a time difference of 16 hours.

3. antibiotic ceftaroline was administered on September 23, 2019, at 8:39 PM. The next antibiotic administration was on September 24, 2019, at 11:17 AM. RPh 1 stated this was a time difference of 14 hours and 20 minutes.

4. antibiotic ceftaroline was administered on September 25, 2019, at 10:55 PM. The next antibiotic administration was on September 26, 2019, at 1:33 PM. RPh 1 stated this was a time difference of 14 hours and 30 minutes.

5. antibiotic ceftaroline was administered on September 30, 2019, at 9:10 AM. The next antibiotic administration was on September 30, 2019, at 11:46 PM. RPh 1 stated this was a time difference of 14 hours.

During record review and concurrent interview with the Nurse Director 1 (ND 1) on October 31, 2019, at 3:30 PM, Patient 2's medical record was reviewed with the ND 1. The medical record indicated the first medication order for the antibiotic ceftaroline, with an ordered frequency of every 12 hours, a start date of September 11, 2019, at 11:40 AM, and a stop date of September 18, 2019, at 4:49 PM. The medical record indicated the second medication order for the antibiotic ceftaroline, with an ordered frequency of every 12 hours, a start date of September 20, 2019, at 9:41 AM and a stop date of October 3, 2019, at 5:25 PM. During a concurrent interview, the ND 1 acknowledged the above two physician orders. The ND 1 stated the time window policy was 30 minutes before or after for an antibiotic medication ordered with a frequency of 12 hours. During record review and concurrent interview, the ND 1 stated that there was more than 12.5 hours from the previous antibiotic ceftaroline administration at the following dates and times and there was no documentation in the medical record the physician was notified:
-September 12, 2019 at 10:21 AM
-September 14, 2019 at 2:52 PM
-September 17, 2019 at 6:20 PM
-September 18, 2019 at 4:49 PM
-September 25, 2019 at 1:41 PM
-September 26, 2019 at 1:33 PM
-September 27, 2019 at 9:53 PM
-September 30, 2019 at 11:46 PM

During record review and concurrent interview with the ND 1 on October 31, 2019, at 4:50 PM, Patient 17's medical record was reviewed with ND 1. The medical record indicated an IV fluid order containing dextrose (sugar) 5% (concentration) 1000 milliliters (mL - a unit of measurement) with 40 milliequivalents (mEq) of the potassium chloride (supplement) to infuse continuously at a rate of 70 mLs per hour. The medical record indicated the IV fluid order had a "Start Date" of August 31, 2019, at 1 PM, and a "Stop Date" of September 4, 2019, at 6:01 PM. The medical record indicated that three IV fluid bags were administered to Patient 17 on September 2, 2019, at 12:41 AM; on September 3, at 6:50 AM; and September 4, 2019, at 6:20 AM. During a concurrent interview, ND 1 acknowledged the medical record indicated a total of three IV fluid bags were administered to Patient 17 for the duration of the continuous IV fluid order on September 2, 2019, at 12:41 AM; on September 3, at 6:50 AM; and September 4, 2019, at 6:20 AM.

During interview with the ND 1 on November 1, 2019, at 9:39 AM, the ND 1 stated there was no requirement to document physician notification in the medical record. The ND 1 stated the "Doctors see the MAR [Medication Administration Record - section of the medical record where administered drugs are documented]. Physicians need to go see MAR."

During record review and concurrent interview with the ND 1 and Registered Pharmacist 2 (RPh 2) on November 1, 2019, at 11:11 AM, Patient 17's medical record was reviewed. The medical record did not indicate a clarification on the medication order for the IV fluid containing dextrose 5% with 40 mEq of potassium chloride. During a concurrent interview, the ND 1 acknowledged the physician order on August 31, 2019, and the medication order was first administered to the patient on September 2, 2019, at 12:41 AM. The ND 1 stated there was no clarification order for the IV fluid with added potassium chloride order dated August 31, 2019. The ND 1 stated "we should have more bags" in reference only three IV fluid bags were administered to Patient 17 between August 31, 2019, and September 4, 2019. The ND 1 stated the expectation is to follow the physician's orders. The ND 1 and RPh 2 stated there was no hold order for the IV fluid with added potassium chloride. The ND 1 and RPh 2 were unable to show documentation in the medical record that the physician was notified about missed and/or late administrations for Patient 17's IV fluids with potassium chloride.

A review of Patient 17's medical record indicated potassium (electrolyte) laboratory values measured 3.3 on August 30, 2019, and measured 3.4 on August 31, 2019, at 9:32 AM. The medical record indicated a normal range between 3.6 to 5.2 milliequivalents per liter (units of measurement) for potassium laboratory values.

A review of the facility's policy and procedure titled "Ordering, Preparation, and Administration of Medications" dated April 2019, indicated:

"E. Medication Administration ...1. An MD [Physician - Medical Doctor], RN [Registered Nurse], LVN [Licensed Vocational Nurse] or student nurse under the direct supervision of an RN, may administer FDA [Food and Drug Agency - federal agency to protect public health by ensuring safe and effective drugs] approved and investigational medications in accordance with the Six Rights of medication administration. ...Right time ...

H. Medication Administration Guidelines ...

6. ALL TIME CRITICAL MEDICATIONS must be administered within 30 minutes before or after the schedule time...Antibiotics.

11. Missed or late administration of medications: In all cases, exceptions to this are those where there is a parameter within which nursing staff are allowed to use their own judgement regarding the timing of first or subsequent doses, further clarification is required from the ordering physician. The following are reasons within which nursing staff can use their judgement regarding the rescheduling of missed or late doses and must notify the physician ...Patient being temporarily away from the nursing unit ...Patient refusal...Patient inability to take the medication ...Problems related to medication availability.

12. IVPB's are administered on the following schedule...q12h [every 12 hours] Piggybacks [IV medications to be infused] given at 0900 [9 AM] and 2100 [9 PM]."

A review of the facility's policy and procedure titled "Medication Error Reporting" dated March 2019, indicated "A medication error: an event that may cause patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including ...administration ...Procedure ...document in the medical record the patients' attending physician was notified."

A review of the facility's policy and procedure titled "Policy Management" dated July 2017 indicated "Objectives ...To assure that regulatory guidelines are followed" and "Definitions ...POLICY - A POLICY is a description of an overall purpose or objective which serves as a guideline for decision-making as questions arise during the normal course of operations. It establishes the parameters within which management and staff operates. The hospital and its departments policies which are interrelated. The format of a policy statement, definitions, descriptions of accountability and policy guidelines."